NIH Launches Human Safety Study of Ebola Vaccine Candidate

There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection.

—Anthony S. Fauci, MD

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched initial human testing of an investigational vaccine to prevent Ebola virus disease, according to a news release issued by NIH. The early-stage trial has begun initial human testing of a vaccine codeveloped by NIAID and GlaxoSmithKline (GSK) to evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing is taking place at the NIH Clinical Center in Bethesda, Maryland.

First in Series of Accelerated Safety Studies

The study is the first of several phase I clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch later in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a phase I safety study of the vaccine among healthy adults in that country.

Urgent Need for Protective Vaccine

The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1,400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.

“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” said NIAID Director Anthony S. Fauci, MD. “The NIH is playing a key role in accelerating the development and testing of investigational Ebola vaccines.”

The investigational vaccine now entering phase I trials was designed by Nancy J. Sullivan, PhD, Chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC). She worked in collaboration with researchers at the VRC, the U.S. Army Medical Research Institute of Infectious Diseases, and Okairos, a Swiss-Italian biotechnology company acquired by GSK in 2013.

The phase I clinical trial, called VRC 207, is being led by Principal Investigator Julie E. Ledgerwood, DO, Chief of the VRC’s clinical trials program, and will be conducted among 20 healthy adults ages 18 to 50 years.

In parallel, NIH has partnered with an international consortium to test the same NIAID/GSK monovalent vaccine candidate. The vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in England and among 40 healthy volunteers in Mali by the University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali.